Business Operations Manager

Senior Director, Global Managed Access Programs, Strategy & Operations

Company
Neurocrine Biosciences
Location
CH Allschwil
Posted
Posted 6 days ago

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The job

Who We Are

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie )

At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

About the Role

The Senior Director, Global Managed Access Programs, Strategy & Operations will provide strategic and operational leadership for the development and execution of Neurocrine's global Managed Access Programs (MAP) (eg, early access, post-trial access, name patient sales, etc.), enabling appropriate access to Neurocrine medicines for patients in countries where traditional commercial access is not yet available or is not planned.

This individual will serve as the enterprise leader for managed access strategy and execution, bringing together Medical Affairs, Lifecycle Management, Market Access, Commercial, Regulatory Affairs, Pharmacovigilance, Quality, Technical Operations/Supply Chain, Legal, Compliance, Finance and other partners to determine where and how MAP should be implemented across the Neurocrine portfolio.

The Senior Director will be accountable for translating asset and lifecycle strategy into scalable, compliant and operationally executable access pathways across countries. The Senior Director will support managed access planning across the product lifecycle (eg, Early/Expanded Access Programs, Single/Named Patient Access, cohort programs, Post-Trial Access, and other pre- and post-approval access pathways, as appropriate). The role will lead the selection, oversight and governance of external partners responsible for program administration, regulatory coordination, distribution and other access services, while ensuring Neurocrine maintains appropriate strategic oversight, decision-making and accountability.

This role requires deep expertise in the complex regulatory, operational, supply and access considerations associated with providing medicines outside traditional commercial channels. The successful candidate will combine strategic thinking with strong operational leadership and will be able to navigate highly matrixed, time-sensitive situations where patient need, regulatory requirements, supply considerations and long-term asset strategy intersect. _

Your Contributions (include, but are not limited to)

Global Managed Access Program Strategy

  • Develop and lead Neurocrine's global strategy and operating model for MAP across commercial and development-stage assets, in alignment with overall asset, lifecycle and geographic expansion strategies
  • Establish scalable processes, governance, and operational capabilities while recognizing that managed access strategies should be tailored to the specific needs of each asset, patient population, geography, and stage of development
  • Partner with Medical Affairs, Lifecycle Management, Commercial, Market Access, Regulatory and other functions to assess when an MAP is appropriate and define the objectives, geographic scope, timing, eligibility framework and operating model for each program
  • Lead country and regional prioritization and feasibility assessments, considering unmet medical need, regulatory pathways, anticipated patient demand, local treatment availability, commercial launch plans, pricing and reimbursement timelines, supply requirements and operational complexity
  • Ensure MAP planning is incorporated proactively into asset lifecycle and launch planning rather than managed solely in response to individual patient requests
  • Develop strategies that allow Neurocrine to responsibly address immediate patient need while preserving flexibility as regulatory approval, reimbursement, commercial footprint and broader access strategies evolve

Program Design & Operational Execution

  • Lead the end-to-end design and operationalization of MAPs, establishing clear implementation plans, timelines, decision points, accountabilities and escalation pathways
  • Lead or facilitate cross-functional MAP working groups to develop program-specific access strategies including exit and transition strategy
  • Establish scalable processes for physician requests, patient eligibility assessment, program enrollment, product ordering and fulfillment, program renewals and discontinuation or transition
  • Partner with Regulatory Affairs to understand and navigate country-specific requirements for unlicensed or investigational medicine access, importation, labeling, documentation and regulatory submissions
  • Partner closely with Technical Operations and Supply Chain to develop demand forecasts, assess supply feasibility, establish appropriate distribution models and ensure reliable product availability
  • Ensure appropriate integration of Pharmacovigilance, Quality, product complaint management, data privacy and other compliance requirements into each program
  • Anticipate operational risks and emerging patient access issues and establish mitigation and contingency plans to ensure continuity of treatment wherever appropriate

External Partner & Vendor Leadership

  • Lead the strategy, selection and governance of external MAP partners, distributors and other service providers
  • Establish clear roles, responsibilities, service-level expectations, decision rights, escalation pathways and performance metrics with external partners
  • Maintain senior-level relationships with key strategic vendors and hold partners accountable for program quality, responsiveness, regulatory compliance, patient and HCP experience, and operational performance
  • Assess the external access landscape and recommend new capabilities, partnerships, technologies or operating models that improve Neurocrine's ability to provide compliant and efficient patient access globally

Cross-Functional Governance

  • Establish and lead cross-functional governance for MAP, ensuring appropriate representation and decision-making across Medical Affairs, Lifecycle Management, Regulatory, Market Access, Commercial, Supply Chain, Quality, Pharmacovigilance, Legal, Compliance and Finance
  • Define enterprise policies, standards, SOPs, decision frameworks and governance processes for NPP initiation, operation, expansion and discontinuation
  • Establish clear processes for assessing new country or patient access requests, including defined decision criteria and escalation pathways for complex or time-sensitive situations
  • Serve as the internal subject matter expert for MAP and advise senior leadership and asset teams on global access options, risks, trade-offs and recommendations

Posted by Neurocrine Biosciences. Some listings are shortened, so open the full posting for the rest.

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